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Clinical Trial Summary

Multi-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.


Clinical Trial Description

This study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (SUI) indicated for AMS sling systems at various time points. The study duration is 2 year with an estimated 200 enrollment. The outcomes of the treatment will be evaluated via pad weight test, cough stress test, QoLs,and other patient administered questionnaires. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00541151
Study type Observational
Source American Medical Systems
Contact
Status Unknown status
Phase Phase 4
Start date September 2007
Completion date November 2010

See also
  Status Clinical Trial Phase
Completed NCT05053373 - Evaluation of Integrated Optimization Schemes for Female Stress Incontinence N/A
Completed NCT04140253 - Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence N/A